Metastatic CancerPhase 1NCT03758781
IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors
A Phase 1 study testing IRX 2 and Nivolumab in people with Metastatic Cancer and Recurrent Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This study is to determine the safety of IRX-2 Regimen combined with Nivolumab in patients with recurrent metastatic solid tumors. Researchers believe that this combination will have a tolerable safety profile and will increase the response rate in comparison to Nivolumab alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Recurrent Cancer, Solid Tumor
- What is being tested?
- IRX 2 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2019to 11 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Participants must have histologically or cytologically confirmed renal cell carcinoma,urothelial carcinoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck or melanoma.
- Participants must have recurrent or metastatic disease that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
- Must be willing and able to give informed consent and adhere to protocol therapy; written informed consent and any locally required authorization must be obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
- Prior exposure to PD-1/PD-L1 inhibitor monotherapy, or prior exposure to CTLA-4 inhibitor monotherapy is allowed.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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- Adequate normal organ and marrow function
- Participants who are receiving therapeutic anti-coagulant therapy are eligible.
- Palliative radiation therapy is allowed to non-target lesions at the discretion of the treating physician.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.1.
- Life expectancy of greater than 3 months.
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment.
- Body weight must be greater than 66 pounds.
Who cannot join
- Prior exposure to a combination of IRX-2 regimen, PD-1/PD-L1 inhibitors and CTLA-4 inhibitors are excluded. Prior exposure to PD-1/PD-L1 inhibitors is allowed.
- Radiation therapy with a curable intent within 30 days of first dose of study treatment is excluded. However, radiation therapy with a palliative intent is allowed to treat after 14 days from the last dose of radiation.
- Any medical contraindications or previous therapy that would preclude treatment with the IRX-2 Regimen, or nivolumab.
- Any unresolved toxicity Grade 2 or greater from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
- Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with IRX-2, or nivolumab may be included only after consultation with the study physician.
- Active or prior documented autoimmune or inflammatory disorders
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- Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment. Some exceptions apply.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- History of allogenic organ transplantation.
- Symptomatic cardiopulmonary disease, coronary artery disease, serious arrhythmia or chronic lung disease. Participants with these conditions who are stable with relatively minor symptoms and who are appropriate candidates for systemic treatments need not be excluded.
- Myocardial infarction within the last 3 months.
- Known infection with hepatitis B, hepatitis C, or HIV.
- Signs or symptoms of systemic infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection).
- Clinically significant gastritis or peptic ulcer disease
- Stroke or other symptoms of cerebral vascular insufficiency within the last 3 months.
- Allergy to ciprofloxacin (or other quinolones).
- Previous diagnosis of invasive cancer from which the individual is not disease-free AND that has required treatment within the past 3 years, except for superficial skin, cervical cancer in-situ, or early stage prostate or bladder cancer (i.e. treatment with curative intent and long term disease-free expectations).
- History of leptomeningeal carcinomatosis
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ effective birth control from screening to 1 year after the last dose of study treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: The IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors: A Phase 1b Study to Evaluate the Safety, Determine Recommended Phase 2 Dose (RP2D), and Investigate the Biologic and Clinical Activity
This study is to determine the safety of IRX-2 Regimen combined with Nivolumab in patients with recurrent metastatic solid tumors. Researchers believe that this combination will have a tolerable safety profile and will increase the response rate in comparison to Nivolumab alone.
Read the detailed description
The first phase of this trial is to establish the safety of IRX-2 Regimen combined with Nivolumab. The IRX-2 Regimen is a 21-day regimen of cyclophosophamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 18. If no dose limiting toxicities (DLTs) are observed during the first 4 weeks of treatment, the enrollment will continue in a dose expansion phase. If there is a study treatment related DLT in 1 of 6 patients, the same dose will be investigated at the dose expansion cohorts. If study treatment related DLT is observed in 2 of 6 patients, accrual will be stopped and new dose levels or treatment sequences will be considered.
- Conditions
- Metastatic Cancer, Recurrent Cancer, Solid Tumor, Renal Cell Carcinoma, Urothelial Carcinoma, NSCLC
- Being tested
- IRX 2, Nivolumab
- Medical subject headings
- Neoplasm Metastasis, Recurrence, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Carcinoma, Squamous Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRX 2Drug
IRX-2 Regimen: 21 day regimen of cyclophosphamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 18. This 21 day regimen will be given every 12 weeks.
NivolumabDrug
Nivolumab 240 mg will be given via IV infusion once every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IRX-2 Regimen combined with Nivolumab | Experimental | IRX-2 Regimen (4 ml) combined with Nivolumab (240 mg) Receives: Drug: IRX 2; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience Dose Limiting Toxicities (DLTs)
A DLT is defined as any Grade 3 or higher toxicity which occurs during the DLT evaluation period of 4 weeks (during Cycle 1 Day 1 and Cycle 1 Day 28) and considered related to study treatment. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded.
Measured: Up to Day 28
Secondary outcomes (2)
Objective Response Rate
Objective response determined using Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 and Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.
Measured: Up to 12 months
Progression Free Survival of combination therapy
Progression free survival defined as the time from Day 1 of treatment to evidence of progression. Progression will be defined by RECIST Version 1.1
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start13 Feb 2019
- Primary completion21 Feb 2021
- Study completion11 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rohit Jain, MD, MPH, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758781
- Sponsor's protocol ID
- MCC-19491
- Status last verified
- Apr 2023
- First submitted
- 28 Nov 2018
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors: A Phase 1b Study to Evaluate the Safety, Determine Recommended Phase 2 Dose (RP2D), and Investigate the Biologic and Clinical Activity
- ClinicalTrials.gov ID
- NCT03758781
- Acronym / sponsor ID
- MCC-19491
- Conditions
- Metastatic Cancer, Recurrent Cancer, Solid Tumor, Renal Cell Carcinoma, Urothelial Carcinoma, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 21 Feb 2021 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to determine the safety of IRX-2 Regimen combined with Nivolumab in patients with recurrent metastatic solid tumors. Researchers believe that this combination will have a tolerable safety profile and will increase the response rate in comparison to Nivolumab alone.
Detailed description
The first phase of this trial is to establish the safety of IRX-2 Regimen combined with Nivolumab. The IRX-2 Regimen is a 21-day regimen of cyclophosophamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 18. If no dose limiting toxicities (DLTs) are observed during the first 4 weeks of treatment, the enrollment will continue in a dose expansion phase. If there is a study treatment related DLT in 1 of 6 patients, the same dose will be investigated at the dose expansion cohorts. If study treatment related DLT is observed in 2 of 6 patients, accrual will be stopped and new dose levels or treatment sequences will be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IRX-2 Regimen combined with Nivolumab | Experimental | Drug: IRX 2, Drug: NivolumabIRX-2 Regimen (4 ml) combined with Nivolumab (240 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- At least 18 years of age
- Participants must have histologically or cytologically confirmed renal cell carcinoma,urothelial carcinoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck or melanoma.
- Participants must have recurrent or metastatic disease that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
- Must be willing and able to give informed consent and adhere to protocol therapy; written informed consent and any locally required authorization must be obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
- Prior exposure to PD-1/PD-L1 inhibitor monotherapy, or prior exposure to CTLA-4 inhibitor monotherapy is allowed.
Key exclusion criteria (20 listed)
- Prior exposure to a combination of IRX-2 regimen, PD-1/PD-L1 inhibitors and CTLA-4 inhibitors are excluded. Prior exposure to PD-1/PD-L1 inhibitors is allowed.
- Radiation therapy with a curable intent within 30 days of first dose of study treatment is excluded. However, radiation therapy with a palliative intent is allowed to treat after 14 days from the last dose of radiation.
- Any medical contraindications or previous therapy that would preclude treatment with the IRX-2 Regimen, or nivolumab.
- Any unresolved toxicity Grade 2 or greater from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
- Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with IRX-2, or nivolumab may be included only after consultation with the study physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRX 2IRX-2 Regimen: 21 day regimen of cyclophosphamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 18. This 21 day regimen will be given every 12 weeks. | Drug | IRX-2 Regimen combined with Nivolumab |
| NivolumabNivolumab 240 mg will be given via IV infusion once every 2 weeks. | Drug | IRX-2 Regimen combined with Nivolumab |
Primary outcome
Number of Participants Who Experience Dose Limiting Toxicities (DLTs)
Time frame: Up to Day 28
A DLT is defined as any Grade 3 or higher toxicity which occurs during the DLT evaluation period of 4 weeks (during Cycle 1 Day 1 and Cycle 1 Day 28) and considered related to study treatment. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded.
2 secondary outcomes
Objective Response Rate
Time frame: Up to 12 months
Progression Free Survival of combination therapy
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Moffitt Cancer Center Clinical Trials WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohit Jain, MD, MPH principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IRX 2 and Nivolumab in people with Metastatic Cancer and Recurrent Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience Dose Limiting Toxicities (DLTs) (time frame: Up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.